Ortho Biotech Inc.


• Immunosuppressive monoclonal antibody with singular specificity to CD3 antigen of human T cells

Mechanism of Action

• Blocks the function of CD3 molecule in the membrane of human T cells, which has been associated in vitro with the antigen recognition structure of human T cells that is essential for signal trans-duction


• Treatment of acute renal allograft rejection as soon as it is diagnosed

• Treatment of steroid-resistant acute cardiac allograft rejection

• Treatment of steroid-resistant acute hepatic allograft rejection


• Hypersensitivity to muromonab-CD3 and/or any product of murine origin

• Antimurine antibody titers >1:1000

• Uncompensated heart failure or fluid overload

• History of seizures

• Determined to be or suspected of being pregnant or breast-feeding


• Cytokine release syndrome, ranging from a mild, self-limited, flu-like syndrome to a less-frequently reported severe, life-threatening shock-like reaction, has been associated with first few doses

• Can be attenuated by premedicating with methylprednisolone, 8 mg/kg, given 1 to 4 hours prior to first injection

• Anaphylactic reactions

• Neuropsychiatric events, including seizures, encephalopathy, cerebral edema, aseptic meningitis, and headache

• Risk of infection and neoplasia

• Patients should be managed in a facility equipped and staffed for cardiopulmonary resuscitation

Special Precautions

• Clear chest X ray and weight restriction of <3% above patient's minimum weight during the week prior to injection

• If patient's temperature exceeds 37.8°C, it should be lowered with antipyretics before each injection

• Periodic monitoring to ensure muromonab-CD3 levels >800 ng/mL and CD3+ cell levels <25 cell/mm3

• Potentially serious signs and symptoms with immediate onset are likely due to hypersensitivity and therapy should be discontinued

• Antiseizure precautions should be undertaken

• Patient should be monitored for signs of infection and/or lymphoproliferative disorders

• Antimurine antibody titers should be monitored after therapy with muromonab-CD3

• As with other immunosuppressives, arterial or venous thromboses of allografts and other vascular beds have been reported

• Pregnancy Category C

Appendix I

Muromonab-CD3 (cont d)

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